The Improved Ballet Shoe: a Study on the Effect of an Ort... | NCT03397927

Studies
The Improved Ballet Shoe: a Study on the Effect of an Orthosis on Pain During Dancing on Pointe Shoes

NCT03397927

Sponsor

Maastricht University Medical Center

Status

Withdrawn

Last Update Posted

Jan 12, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Ballet Dancers

Interventions

orthosis

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No response to EC questions were given

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

May 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Jan 23, 2014

First Submission Date that Met QC Criteria

Jan 5, 2018

First Posted Date

Jan 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2018

Last Update Posted Date

Jan 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An orthosis in the ballet shoe to see if pain reduction during dancing on pointes will decrease.

One group of pre-preprofessional ballet dancers will receive an orthosis and will train during four weeks with it. The other group without a orthosis will be the control group.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
orthosis	Experimental		Device: orthosis

Name	Type	Description	Arm Group Labels	Other Names
orthosis	Device		orthosis

Measure	Description	Time Frame
VAS-score		four weeks

Measure	Description	Time Frame
lower extremities muscle ratio		four weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

girls on preprofessional ballet schools with a minimum of 30 minutes professional training a week;
12 to 18 years old
pain during dancing on pointes

Exclusion Criteria:

experience with wearing a orthosis in their ballet shoe

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht UMC		Maastricht	Limburg	6229	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009989	Orthotic Devices

Ancestor Terms

ID	Term
D009983	Orthopedic Equipment
D013523	Surgical Equipment
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided